Mental Health

Neuromodulation

The somatic bet where evidence actually caught up — and the test of whether it stays caught up. SAINT/SNT went from a 30-patient trial underpinning FDA 510(k) clearance (K220177, ~2022) and nationwide commercial rollout to a sham-controlled confirmatory RCT (World Psychiatry 2026, n=48: remission 50.0% vs 20.8% sham) four years later — replicating the direction of effect at far more modest magnitude than the "80-90%" figure the original trial spawned. Watch: payer/Medicare coverage decisions, real-world deployment outcomes vs the confirmatory numbers (the esketamine-style trial-to-real-world gap risk), the EEG-biomarker (L-ACC beta power) treatment-selection angle, and further confirmatory work.

STATUS · OPEN OPENED · 2026-08-07 LAST SEEN · 2026-08-07

2026 — The confirmatory trial lands, four years after clearance — and replicates at half the touted magnitude

Kratter et al. published a sham-controlled confirmatory RCT of Stanford Neuromodulation Therapy (SAINT) in World Psychiatry (n=48, 24 active / 24 sham): remission 50.0% vs 20.8% (p=0.035), response 54.2% vs 25.0% (p=0.039) — replicating the direction of effect four years after the 30-patient trial that carried the FDA 510(k) clearance, at far more modest magnitude than the “80-90%” figure that circulated off the original. The study also reports left-ACC beta power as a predictive EEG biomarker — a treatment-selection angle the matching strand (mh-q02) tracks separately. (PMID 41536095) (wave: mh-q03) ⟨steer 2026-08-07⟩

2022 — Clearance and commercial rollout on a 30-patient trial

FDA cleared SNT via 510(k) (K220177) on Cole et al.’s original American Journal of Psychiatry RCT (n=30), and commercial SAINT rollout followed nationwide — deployment preceding confirmatory evidence by roughly four years, the same pattern the psychedelic sprint is running now. The difference, and the reason this thread exists: here the confirmatory trial eventually happened and held. (wave: mh-q03) ⟨steer 2026-08-07⟩